2026-09-21 · KeXinMaterials 編集チーム

ISO 13485 Medizinprodukt QMS + Schutzkoffer B2B-Compliance-Leitfaden

ISO 13485:2016 "Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke" ist der globale Standard für Medizinprodukt-QMS. Erforderlich für Medizinprodukte-Hersteller + Lieferanten + Dienstleister. Kombiniert mit MDR (EU) 2017/745 (EU) + FDA 21 CFR 820 (US).

ISO 13485 Scope + Versions

ISO 13485:2016 current revision. Based on ISO 9001:2008 structure with medical device-specific additions. Required for medical device QMS.

ISO 13485:2016: Current edition (March 2016). Replaces ISO 13485:2003.

Publisher: ISO (International Organization for Standardization). TC 210 (Quality management and corresponding general aspects for medical devices).

Scope: QMS requirements for medical device manufacturers + suppliers + service providers.

Medical device definition: Per ISO 13485, any instrument, apparatus, implant, in vitro reagent, or other article intended for medical purposes.

Geographic: International standard adopted globally. EU MDR references ISO 13485. FDA 21 CFR 820 harmonizes with ISO 13485. Canada, Japan, Australia, Brazil recognize.

Certifying bodies: ANAB (US), UKAS (UK), DAkkS (Germany), COFRAC (France), BSI (Netherlands), TÜV SÜD (Germany). All IAF MLA accredited.

Certificate validity: 3 years initial + annual surveillance + recertification.

ISO 14971 (Risk Management): Required companion standard. All ISO 13485-certified organizations must implement ISO 14971.

IEC 62304 (Medical Device Software): Required for medical device software. Companion standard.

IEC 60601 (Medical Electrical Equipment): Required for medical electrical equipment. Companion standard.

B2B relevance: For box-beeaa B2B buyers in medical device / pharma / diagnostic, ISO 13485 compliance required for protective cases carrying medical devices + pharma cold chain + diagnostic equipment.

ISO 13485 Requirements

ISO 13485 includes 8 main clauses with medical device-specific additions on document control, design control, purchasing, production, traceability, validation.

Clause 4 - Quality Management System: Documented QMS + role responsibilities + management representative.

Clause 5 - Management Responsibility: Management commitment + customer focus + quality policy + quality objectives + management review.

Clause 6 - Resource Management: Human resources + infrastructure + work environment + contamination control.

Clause 7 - Product Realization: Planning + customer-related processes + design + development + purchasing + production + service.

Clause 8 - Measurement, Analysis, Improvement: Monitoring + measurement + control of nonconforming product + analysis + improvement + CAPA.

Section 4.2.4 - Control of Records: Medical device records retained per regulatory requirement (typically 2 years after device discontinuation or longer).

Section 7.3 - Design and Development: Design planning + inputs + outputs + review + validation + changes + transfer records. Documented design history file (DHF) for FDA.

Section 7.4 - Purchasing: Supplier evaluation + purchasing information + verification of purchased product. Supplier controls critical.

Section 7.5.1 - Control of Production: Production process controls + work instructions + monitoring equipment + in-process inspection.

Section 7.5.3 - Identification and Traceability: Each medical device uniquely identified. Traceability from raw material to delivered product + to patient (UDI per EU MDR + FDA).

Section 7.5.5 - Particular Requirements for Sterile Medical Devices: Sterilization process validation + routine monitoring.

Section 7.5.6 - Validation of Processes: Validation of production processes (IQ/OQ/PQ). Including software validation per IEC 62304.

Section 8.2.2 - Complaint Handling: Customer complaint recording + investigation + root cause analysis + corrective action + regulatory reporting (MDR vigilance for serious incidents).

Section 8.5 - Improvement: CAPA (Corrective Action / Preventive Action). Mandatory for medical device nonconformities.

B2B relevance: For B2B medical device cases, ISO 13485 compliance required. Supplier audit + DoC + ISO 14971 risk analysis + IEC 62304 (if embedded software).

ISO 14971 Risk Management

ISO 14971:2019 "Medical devices - Application of risk management to medical devices" - mandatory companion to ISO 13485.

ISO 14971:2019: Current edition (2019). Replaces ISO 14971:2007.

Risk management process: (1) Risk analysis. (2) Risk evaluation. (3) Risk control. (4) Residual risk evaluation. (5) Risk management review. (6) Production + post-production information.

Risk analysis: Identify hazards + estimate risks (severity x probability) for each hazard + hazardous situation.

Severity scale: Negligible, Minor, Serious, Critical, Catastrophic. ISO 14971:2019 simplified to 5 levels.

Probability scale: Improbable, Remote, Occasional, Frequent, Frequent. Probability per use / per device lifetime.

Risk acceptability: Risk matrix maps severity x probability. Unacceptable risks must be reduced (as low as reasonably practicable).

Risk control measures: Inherent safe design + protective measures (case / barrier) + information for safety (labeling / instructions).

Risk management file: Documents risk analysis + evaluation + control + residual risk + post-production plan. Required for CE marking.

Risk management plan: Defines scope + responsibilities + acceptability criteria + verification activities.

Post-production: Monitor actual incidents + complaints + recalls + service data. Update risk analysis based on real-world data.

ISO 14971 + IEC 62304 integration: Software risk classification + testing requirements per IEC 62304 (Class A / B / C software).

B2B medical case risk management: Identify hazards (drop, vibration, ESD, temperature, contamination, loss of data) + estimate severity (e.g., wrong diagnostic = critical) + apply controls (case + cushioning + labeling) + verify.

B2B recommendation: For medical device cases, require ISO 14971 risk management file + risk analysis for case + IEC 62304 (if embedded software) + post-production monitoring plan.

MDR (EU) 2017/745 + FDA 21 CFR 820

MDR (EU) 2017/745 (EU Medical Device Regulation) + FDA 21 CFR 820 (US Quality System Regulation) are regional regulatory frameworks. ISO 13485 harmonizes with both.

MDR (EU) 2017/745: EU Medical Device Regulation. Entered force May 2017. Apply from May 2021 (with extensions). Replaces MDD 93/42/EEC.

MDR scope: All medical devices placed on EU market. Includes accessories + devices for cleaning / disinfection / sterilization.

MDR classification: Class I (low risk) + Class IIa (low-medium) + Class IIb (medium-high) + Class III (high). Higher class = stricter requirements.

MDR conformity assessment: Class I self-declaration. Class IIa + IIb + III require Notified Body (e.g., TÜV SÜD, BSI, DEKRA) certification.

MDR technical documentation: Technical File or Design Dossier per device class. Must include ISO 14971 risk analysis.

MDR Unique Device Identification (UDI): Each device has UDI-DI (device identifier) + UDI-PI (production identifier). Per Article 27.

MDR post-market surveillance: PMS plan + PMS report + PSUR (Periodic Safety Update Report) for Class IIa/IIb/III.

MDR vigilance reporting: Serious incidents must be reported to competent authority within 15 days (death / serious deterioration). Field Safety Corrective Action (FSCA) if needed.

FDA 21 CFR 820: US Quality System Regulation. 30 years old (current version 2024 update). ISO 13485 harmonized via 2018 agreement.

FDA classification: Class I (general controls) + Class II (general + special controls, often 510(k)) + Class III (PMA, premarket approval).

FDA 510(k): Premarket notification for Class II devices. Demonstrate substantial equivalence to predicate device.

FDA PMA: Premarket approval for Class III devices. Full clinical data required.

FDA Establishment Registration: All medical device manufacturers must register FDA Establishment + list devices annually.

B2B recommendation: For US + EU markets, require ISO 13485 + MDR compliance (EU) + FDA 21 CFR 820 (US) + 510(k) or PMA documentation as applicable.

ISO 13485 + B2B Procurement Workflow

B2B procurement workflow for medical device protective cases. 5-step + ISO 13485 supplier qualification + documentation.

Step 1: Determine medical device class (I, IIa, IIb, III) per MDR or FDA classification rules.

Step 2: Specify ISO 13485:2016 certification requirement + ISO 14971 risk management for case.

Step 3: Specify regional regulatory compliance. MDR (EU) / FDA 21 CFR 820 / Japan PMDA / China NMPA / Health Canada.

Step 4: Specify validation requirements. IEC 62304 (if software) + IQ/OQ/PQ (production process) + sterilization validation (if sterile).

Step 5: Specify labeling + UDI requirements. EU MDR UDI-DI + UDI-PI + FDA UDI per 21 CFR 830.

Supplier qualification: ISO 13485 audit (Stage 1 + Stage 2 + annual surveillance) + management representative interview + CAPA history + complaint handling review.

Case validation: Drop test + vibration test + temperature test + ESD test + cleaning test + sterilization compatibility (if sterile device).

Material biocompatibility: ISO 10993-1 if case contacts medical device. Cytotoxicity + sensitization + irritation testing.

Sterilization compatibility: If case or device undergoes sterilization (EtO, gamma, steam, plasma), verify case material compatibility + cycle validation.

Labeling: ISO 15223-1 (medical device symbols) + 21 CFR 801 (US labeling) + MDR Annex I Chapter III (EU labeling). Includes UDI carrier + CE mark + manufacturer + sterility + expiry.

Recordkeeping: 10 years minimum for medical device records (varies by regulation). DHF (Design History File) + DMR (Device Master Record) + DHR (Device History Record).

Cost impact: ISO 13485 + ISO 14971 + IEC 62304 adds 10-25% to medical device component cost. Premium for safety-critical devices.

B2B recommendation: For medical device protective cases, require ISO 13485:2016 + ISO 14971 risk management + regional compliance (MDR / FDA) + IEC 62304 (if software) + ISO 10993-1 (if biocompatibility). Annual audit + recordkeeping.

よくある質問

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